-
Prescribing Information and Abbreviated Prescribing Information
for Oman , AugmentinTM 1 g Tablets Amoxicillin trihydrate +
Potassium clavulanate Content Lab Code: PI-6686 Date of
Preparation: September 2020 Page 1 of 5
Prescribing Information for Oman AugmentinTM 1 g Tablets
Amoxicillin trihydrate + potassium clavulanate QUALITATIVE AND
QUANTITATIVE COMPOSITION Each Augmentin 1 g tablet contains 875 mg
amoxycillin (as amoxycillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate). For a full list of excipients, see
section ‘List of Excipients’. PHARMACEUTICAL FORM White to
off-white, film-coated tablets debossed with “AC” on both sides and
a scoreline on one side. The scoreline is only to facilitate
breaking and ease of swallowing and not to divide into equal doses.
CLINICAL PARTICULARS Therapeutic Indications Augmentin is indicated
for the treatment of the following infections in adults and
children: • Acute bacterial sinusitis (adequately diagnosed) •
Acute otitis media • Acute exacerbations of chronic bronchitis
(adequately diagnosed) • Community-acquired pneumonia • Cystitis •
Pyelonephritis • Skin and soft tissue infections in particular
cellulitis, animal bites, severe dental abscess with spreading
cellulitis. • Bone and joint infections, in particular
osteomyelitis. Consideration should be given to official guidance
on the appropriate use of antibacterial agents. Posology and Method
of Administration Doses are expressed throughout in terms of
amoxicillin/clavulanic acid content except when doses are stated in
terms of an individual component. The dose of Augmentin that is
selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents • The severity and the site of the infection •
The age, weight and renal function of the patient as shown below
The use of alternative presentations of Augmentin (e.g. those that
provide higher doses of amoxicillin and/or different ratios of
amoxicillin to clavulanic acid) should be considered as necessary.
For adults and children ≥ 40 kg, this formulation of Augmentin
provides a total daily dose of 1750 mg amoxicillin/ 250 mg
clavulanic acid with twice-daily dosing and 2625 mg amoxicillin/375
mg clavulanic acid with three times daily dosing when administered
as recommended below. For children < 40 kg, this formulation of
Augmentin provides a maximum daily dose of 1000-2800 mg
amoxicillin/143-400 mg clavulanic acid when administered as
recommended below. If it is considered that a higher daily dose of
amoxicillin is required, it is recommended that another preparation
of Augmentin is selected in order to avoid administration of
unnecessarily high daily doses of clavulanic acid. The duration of
therapy should be determined by the response of the patient. Some
infections (e.g. osteomyelitis) require longer periods of
treatment. Treatment should not be extended beyond 14 days without
review. Adults and children ≥ 40 kg Recommended doses: • standard
dose: (for all indications) 875 mg/125 mg two times a day; • higher
dose - (particularly for infections such as otitis media,
sinusitis, lower respiratory tract infections and urinary tract
infections): 875 mg/125 mg three times a day. Children < 40 kg
Children may be treated with Augmentin tablets, suspensions or
paediatric sachets. Recommended doses: • 25 mg/3.6 mg/kg/day to 45
mg/6.4 mg/kg/day given as two divided doses; • up to 70 mg/10
mg/kg/day given as two divided doses may be considered for some
infections (such as otitis media, sinusitis and lower respiratory
tract infections). As the tablets cannot be divided, children
weighing less than 25 kg must not be treated with Augmentin
tablets. The table below presents the received dose (mg/kg body
weight) in children weighing 25 kg to 40 kg upon administering a
single 875/125 mg tablet
Body weight [kg] 40 35 30 25 Single dose recommended [mg/kg body
weight] (see above) Amoxicillin [mg/kg body weight] per single dose
(1 film-coated tablet)
21.9 25.0 29.2 35.0 12.5 – 22.5 (up to 35)
Clavulanic acid [mg/kg body weight] per single dose (1
film-coated tablet)
3.1 3.6 4.2 5.0 1.8 – 3.2 (up to 5)
Children weighing less than 25 kg should preferably be treated
with Augmentin suspension or paediatric sachets. No clinical data
are available for Augmentin 7:1 formulations regarding doses higher
than 45 mg/6.4 mg per kg per day in children under 2 years. There
are no clinical data for Augmentin 7:1 formulations for patients
under 2 months of age. Dosing recommendations in this population
therefore cannot be made. Elderly No dose adjustment is considered
necessary. Renal impairment No dose adjustment is required in
patients with creatinine clearance (CrCl) greater than 30 ml/min.
In patients with creatinine clearance less than 30 ml/min, the use
of Augmentin presentations with amoxicillin to clavulanic acid
ratio of 7:1 is not recommended, as no recommendations for dose
adjustments are available.
-
Prescribing Information and Abbreviated Prescribing Information
for Oman , AugmentinTM 1 g Tablets Amoxicillin trihydrate +
Potassium clavulanate Content Lab Code: PI-6686 Date of
Preparation: September 2020 Page 2 of 5
Hepatic impairment Dose with caution and monitor hepatic
function at regular intervals. Method of administration Augmentin
is for oral use. Administer at the start of a meal to minimise
potential gastrointestinal intolerance and optimise absorption of
amoxicillin/clavulanic acid. Therapy can be started parenterally
according to the prescribing information of the IV-formulation and
continued with an oral preparation. Contraindications
Amoxicillin-clavulanate is contra-indicated: - in patients with a
history of hypersensitivity to beta-lactams, e.g. penicillins and
cephalosporins - in patients with a previous history of
amoxicillin-clavulanate-associated jaundice/hepatic dysfunction.
Warnings and Precautions Before initiating therapy with
amoxicillin-clavulanate, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins, cephalosporins,
or other allergens. Serious and occasionally fatal hypersensitivity
(anaphylactoid) reactions have been reported in patients on
penicillin therapy. These reactions are more likely to occur in
individuals with a history of penicillin hypersensitivity. If an
allergic reaction occurs, amoxicillin-clavulanate therapy should be
discontinued and appropriate alternative therapy instituted.
Serious anaphylactoid reactions require immediate emergency
treatment with adrenaline. Oxygen, i.v. steroids and airway
management, including intubation, may also be required.
Amoxicillin-clavulanate should be avoided if infectious
mononucleosis is suspected since the occurrence of a morbilliform
rash has been associated with this condition following the use of
amoxicillin. Prolonged use may also occasionally result in
overgrowth of non-susceptible organisms. Pseudomembranous colitis
has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important
to consider its diagnosis in patients who develop diarrhoea during
or after antibiotic use. If prolonged or significant diarrhoea
occurs or the patient experiences abdominal cramps, treatment
should be discontinued immediately and the patient investigated
further. In general, amoxicillin-clavulanate is well tolerated and
possesses the characteristic low toxicity of the penicillin group
of antibiotics. Periodic assessment of organ system functions,
including renal, hepatic and haematopoietic function is advisable
during prolonged therapy. Abnormal prolongation of prothrombin time
(increased INR) has been reported rarely in patients receiving
amoxicillin-clavulanate and oral anticoagulants. Appropriate
monitoring should be undertaken when anticoagulants are prescribed
concurrently. Adjustments in the dose of oral anticoagulants may be
necessary to maintain the desired level of anticoagulation.
Amoxicillin-clavulanate should be used with caution in patients
with evidence of hepatic dysfunction. In patients with renal
impairment, the dosage should be adjusted according to the degree
of impairment. In patients with reduced urine output, crystalluria
has been observed very rarely, predominantly with parenteral
therapy. During the administration of high doses of amoxicillin, it
is advisable to maintain adequate fluid intake and urinary output
in order to reduce the possibility of amoxicillin crystalluria.
Amoxicillin-clavulanate Suspensions/Sachets/Chewable Tablets (where
applicable), contain aspartame, which is a source of phenylalanine
and so should be used with caution in patients with
phenylketonuria. Interactions Concomitant use of probenecid is not
recommended. Probenecid decreases the renal tubular secretion of
amoxicillin. Concomitant use with amoxicillin-clavulanate may
result in increased and prolonged blood levels of amoxicillin, but
not of clavulanic acid. Concomitant use of allopurinol during
treatment with amoxicillin can increase the likelihood of allergic
skin reactions. There are no data on the concomitant use of
amoxicillin-clavulanate and allopurinol. In common with other
antibiotics, amoxicillin-clavulanate may affect the gut flora,
leading to lower oestrogen reabsorption and reduced efficacy of
combined oral contraceptives. In the literature, there are rare
cases of increased international normalised ratio in patients
maintained on acenocoumarol or warfarin and prescribed a course of
amoxicillin. If coadministration is necessary, the prothrombin time
or international normalised ratio should be carefully monitored
with the addition or withdrawal of amoxicillin. In patients
receiving mycophenolate mofetil, reduction in the pre-dose
concentration of the active metabolite mycophenolic acid of
approximately 50% has been reported following commencement of oral
amoxicillin plus clavulanic acid. The change in the pre-dose level
may not accurately represent changes in overall MPA exposure.
Pregnancy and Lactation Pregnancy Reproduction studies in animals
(mice and rats at doses up to 10 times the human dose) with orally
and parenterally administered amoxicillin-clavulanate have shown no
teratogenic effects. In a single study in women with pre-term,
premature rupture of the foetal membrane (pPROM), it was reported
that prophylactic treatment with amoxicillin-clavulanate may be
associated with an increased risk of necrotizing enterocolitis in
neonates. As with all medicines, use should be avoided in
pregnancy, unless considered essential by the physician. Lactation
Amoxicillin-clavulanate may be administered during the period of
lactation. With the exception of the risk of sensitization,
associated with the excretion of trace quantities in breast milk,
there are no known detrimental effects for the breast-fed infant.
Ability to perform tasks that require judgement, motor or cognitive
skills Adverse effects on the ability to drive or operate machinery
have not been observed. Adverse Reactions Data from large clinical
trials were used to determine the frequency of very common to rare
undesirable effects. The frequencies assigned to all other
undesirable effects (i.e., those occurring at 1/10
-
Prescribing Information and Abbreviated Prescribing Information
for Oman , AugmentinTM 1 g Tablets Amoxicillin trihydrate +
Potassium clavulanate Content Lab Code: PI-6686 Date of
Preparation: September 2020 Page 3 of 5
common >1/100 and 1/1000 and 1/10,000 and
-
Prescribing Information and Abbreviated Prescribing Information
for Oman , AugmentinTM 1 g Tablets Amoxicillin trihydrate +
Potassium clavulanate Content Lab Code: PI-6686 Date of
Preparation: September 2020 Page 4 of 5
Incompatibilities None known. Shelf-life As indicated on the
outer packaging. Special Precautions for Storage Store in a dry
place at or below 30°C. Store in the original package in order to
protect from moisture. Tablets in desiccated pouch packs should be
used within 14 days of opening. Nature and Contents of Container
Only moisture-proof containers should be used. AugmentinTM 1 g is
supplied in a carton containing 14 tablets in blisters inside a
desiccated pouch. Manufactured by: SmithKline Beecham Limited*
Worthing, United Kingdom *Member of the GlaxoSmithKline group of
companies. AUGMENTIN is a trademark of the GlaxoSmithKline group of
companies. © 2014 GlaxoSmithKline group of companies. All rights
reserved. GDS Version Number: 21 Version Date: 18 January 2013
Detailed information on this medicinal product can be requested
Via: [email protected] To report Adverse Event/s associated with
the use of GSK product/s, please contact us via [email protected]
All Quality complaints should be reported to the LOC Quality
department mailbox [email protected]. Department
of Pharmacovigilance & Drug Information Directorate General of
Pharmaceutical Affairs & Drug Control Ministry of Health,
Sultanate of Oman Phone Nos. 0096822357687 / 0096822357686 Fax:
0096822358489 Email: [email protected] Website: www.moh.gov.om
Prescribing information for Oman Prepared September 2020 from the
summary of product characteristics version with Date of first
authorisation: 18 January 2013.
mailto:[email protected]
-
Prescribing Information and Abbreviated Prescribing Information
for Oman , AugmentinTM 1 g Tablets Amoxicillin trihydrate +
Potassium clavulanate Content Lab Code: PI-6686 Date of
Preparation: September 2020 Page 5 of 5
Abbreviated Prescribing Information for Oman AugmentinTM 1 g
Tablets
Amoxicillin trihydrate + Potassium clavulanate QUALITATIVE AND
QUANTITATIVE COMPOSITION: Each Augmentin 1 g tablet contains 875 mg
amoxycillin (as amoxycillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate). PHARMACEUTICAL FORM: White to
off-white, film-coated tablets debossed with “AC” on both sides and
a scoreline on one side. Indications: Augmentin is indicated for
the treatment of the following infections in adults and children:
Acute bacterial sinusitis (adequately diagnosed), Acute otitis
media, acute exacerbations of chronic bronchitis (adequately
diagnosed), Community-acquired pneumonia, Cystitis, Pyelonephritis,
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with spreading cellulitis, Bone and
joint infections, in particular osteomyelitis. Posology and Method
of Administration: For adults and children ≥ 40 kg, this
formulation of Augmentin provides a total daily dose of 1750 mg
amoxicillin/ 250 mg clavulanic acid with twice-daily dosing and
2625 mg amoxicillin/375 mg clavulanic acid with three times daily
dosing when administered as recommended below. For children < 40
kg, this formulation of Augmentin provides a maximum daily dose of
1000-2800 mg amoxicillin/143-400 mg clavulanic acid when
administered as recommended below. If it is considered that a
higher daily dose of amoxicillin is required, it is recommended
that another preparation of Augmentin is selected in order to avoid
administration of unnecessarily high daily doses of clavulanic
acid. The duration of therapy should be determined by the response
of the patient. Treatment should not be extended beyond 14 days
without review. Method of administration: Augmentin is for oral
use. Administer at the start of a meal to minimise potential
gastrointestinal intolerance and optimise absorption of
amoxicillin/clavulanic acid. Therapy can be started parenterally
according to the prescribing information of the IV-formulation and
continued with an oral preparation. Contraindications:
Amoxicillin-clavulanate is contraindicated in patients with a
history of hypersensitivity to beta-lactams or history of
amoxicillin-clavulanate-associated jaundice/hepatic dysfunction.
Warnings and Precautions: Before initiating therapy with
amoxicillin-clavulanate, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins, cephalosporins,
or other allergens. Serious and occasionally fatal hypersensitivity
(anaphylactoid) reactions have been reported in patients on
penicillin therapy. These reactions are more likely to occur in
individuals with a history of penicillin hypersensitivity. If an
allergic reaction occurs, amoxicillin-clavulanate therapy should be
discontinued and appropriate alternative therapy instituted.
Serious anaphylactoid reactions require immediate emergency
treatment with adrenaline. Oxygen, i.v. steroids and airway
management, including intubation, may also be required.
Amoxicillin-clavulanate should be avoided if infectious
mononucleosis is suspected since the occurrence of a morbilliform
rash has been associated with this condition following the use of
amoxicillin. Prolonged use may also occasionally result in
overgrowth of non-susceptible organisms. Pseudomembranous colitis
has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important
to consider its diagnosis in patients who develop diarrhoea during
or after antibiotic use. If prolonged or significant diarrhoea
occurs or the patient experiences abdominal cramps, treatment
should be discontinued immediately and the patient investigated
further. In general, amoxicillin-clavulanate is well tolerated and
possesses the characteristic low toxicity of the penicillin group
of antibiotics. Periodic assessment of organ system functions,
including renal, hepatic and haematopoietic, the function is
advisable during prolonged therapy. Abnormal prolongation of
prothrombin time (increased INR) has been reported rarely in
patients receiving amoxicillin-clavulanate and oral anticoagulants.
Appropriate monitoring should be undertaken when anticoagulants are
prescribed concurrently. Adjustments in the dose of oral
anticoagulants may be necessary to maintain the desired level of
anticoagulation. Amoxicillin-clavulanate should be used with
caution in patients with evidence of hepatic dysfunction. In
patients with renal impairment, the dosage should be adjusted
according to the degree of impairment. In patients with reduced
urine output, crystalluria has been observed very rarely,
predominantly with parenteral therapy. During the administration of
high doses of amoxicillin, it is advisable to maintain adequate
fluid intake and urinary output in order to reduce the possibility
of amoxicillin crystalluria. Amoxicillin-clavulanate
Suspensions/Sachets/Chewable Tablets (where applicable), contain
aspartame, which is a source of phenylalanine and so should be used
with caution in patients with phenylketonuria. Interactions:
Concomitant use of probenecid is not recommended. Probenecid
decreases the renal tubular secretion of amoxicillin. Concomitant
use with amoxicillin-clavulanate may result in increased and
prolonged blood levels of amoxicillin, but not of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin
can increase the likelihood of allergic skin reactions. There are
no data on the concomitant use of amoxicillin-clavulanate and
allopurinol. In common with other antibiotics,
amoxicillin-clavulanate may affect the gut flora, leading to lower
oestrogen reabsorption and reduced efficacy of combined oral
contraceptives. In the literature, there are rare cases of
increased international normalised ratio in patients maintained on
acenocoumarol or warfarin and prescribed a course of amoxicillin.
If coadministration is necessary, the prothrombin time or
international normalised ratio should be carefully monitored with
the addition or withdrawal of amoxicillin. In patients receiving
mycophenolate mofetil, reduction in the pre-dose concentration of
the active metabolite mycophenolic acid of approximately 50% has
been reported following commencement of oral amoxicillin plus
clavulanic acid. The change in the pre-dose level may not
accurately represent changes in overall MPA exposure. Pregnancy: As
with all medicines, use should be avoided in pregnancy, unless
considered essential by the physician. Lactation
Amoxicillin-clavulanate may be administered during the period of
lactation with the exception of the risk of sensitization. Adverse
Reactions, Infections and infestations: common Mucocutaneous
candidiasis, nausea, vomiting, Diarrhoea. If any hypersensitivity
dermatitis reaction occurs, treatment should be discontinued.
Overdosage Treatment: GI, symptoms may be treated symptomatically,
with attention to the water/electrolyte balance.
Amoxicillin-clavulanate can be removed from the circulation by
haemodialysis. PHARMACEUTICAL DATA: List of Excipients: Colloidal
silicon dioxide, sodium starch glycollate, magnesium stearate
(E572), microcrystalline cellulose, titanium dioxide (E171),
hydroxypropyl methylcellulose, polyethylene glycol, dimethicone
(silicon oil). Special Precautions for Storage: Store in a dry
place at or below 30°C. Store in the original package in order to
protect from moisture. Tablets in desiccated pouch packs should be
used within 14 days of opening. Nature and Contents of Container:
Only moisture-proof containers should be used. AugmentinTM 1 g is
supplied in a carton containing 14 tablets in blisters inside a
desiccated pouch. Manufactured by: SmithKline Beecham Limited*
Worthing, United Kingdom *Member of the GlaxoSmithKline group of
companies AUGMENTIN is a trademark of the GlaxoSmithKline group of
companies.© 2014 GlaxoSmithKline group of companies. All rights
reserved GDS Version Number: 21 Version Date: 18 January 2013
Detailed information on this medicinal product can be requested
Via: [email protected]. To report Adverse Event/s associated with
the use of GSK product/s, please contact us via
[email protected]. All Quality complaints should be reported to
the LOC Quality department mailbox
[email protected].. Department of
Pharmacovigilance & Drug Information, Directorate General of
Pharmaceutical Affairs & Drug Control, Ministry of Health,
Sultanate of Oman, Phone Nos. 0096822357687 / 0096822357686 Fax:
0096822358489 Email: [email protected] Website: www.moh.gov.om
Prescribing information for Oman Prepared September 2020 from the
summary of product characteristics version with Date of first
authorisation: 18 January 2013.
mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.moh.gov.om/
-
Page 1 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 156 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6687 Date of Preparation: September 2020
Prescribing Information for Oman Augmentin™ 156 mg/5 ml
suspension
Amoxicillin trihydrate - Potassium clavulanate QUALITATIVE AND
QUANTITATIVE COMPOSITION AugmentinTM 156 mg/5 ml suspension: When
reconstituted each 5 ml contains 125 mg amoxicillin (as amoxicillin
trihydrate) and 31.25 mg clavulanic acid (as potassium
clavulanate). For a full list of excipients, see section ‘List of
Excipients’. PHARMACEUTICAL FORMS AugmentinTM 156 mg/5 ml
suspension: Powder for oral suspension. Dry powder for
reconstitution in water, at time of dispensing, to form fruit
flavoured suspension. CLINICAL PARTICULARS Therapeutic Indications
AugmentinTM is indicated for the treatment of the following
infections in adults and children: • Acute bacterial sinusitis
(adequately diagnosed) • Acute otitis media • Acute exacerbations
of chronic bronchitis (adequately diagnosed) • Community-acquired
pneumonia • Cystitis • Pyelonephritis • Skin and soft tissue
infections in particular cellulitis, animal bites, severe dental
abscess with spreading cellulitis • Bone and joint infections, in
particular, osteomyelitis Consideration should be given to official
guidance on the appropriate use of antibacterial agents. Posology
and Method of Administration Doses are expressed throughout in
terms of amoxicillin/clavulanic acid content except when doses are
stated in terms of an individual component. The dose of AugmentinTM
that is selected to treat an individual infection should take into
account: • The expected pathogens and their likely susceptibility
to antibacterial agents. • The severity and the site of the
infection • The age, weight and renal function of the patient as
shown below. The use of alternative presentations of AugmentinTM
(e.g. those that provide higher doses of amoxicillin and/or
different ratios of amoxicillin to clavulanic acid) should be
considered as necessary. For adults and children ≥ 40 kg, these
formulations of AugmentinTM provide a total daily dose of 1500 mg
amoxicillin/375 mg clavulanic acid when administered as recommended
below. For children < 40 kg, these formulations of AugmentinTM
provide a maximum daily dose of 2400 mg amoxicillin/600 mg
clavulanic acid when administered as recommended below. If it is
considered that a higher daily dose of amoxicillin is required, it
is recommended that another preparation of AugmentinTM is selected
in order to avoid administration of unnecessarily high daily doses
of clavulanic acid. The duration of therapy should be determined by
the response of the patient. Some infections (e.g. osteomyelitis)
require longer periods of treatment. Treatment should not be
extended beyond 14 days without review (see Warnings and
Precautions for Use regarding prolonged therapy). Adults and
children ≥ 40 kg One 500 mg/125 mg dose is taken three times a day.
Children < 40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given
in three divided doses. Children may be treated with AugmentinTM
tablets, suspensions or paediatric sachets. Children aged 6 years
and below or weighing less than 25 kg should preferably be treated
with Augmentin suspension or paediatric sachets. For AugmentinTM
625 mg tablets: As the tablets cannot be divided, children weighing
less than 25 kg must not be treated with Augmentin tablets. The
table below presents the received dose (mg/kg body weight) in
children weighing 25 kg to 40 kg upon administering a single
500/125 mg tablet.
Body weight [kg] 40 35 30 25 Single dose recommended [mg/kg body
weight] (see above) Amoxicillin [mg/kg body weight] per
single dose (1 film-coated tablet) 12.5 14.3 16.7 20.0 6.67 –
20
Clavulanic acid [mg/kg body weight] per
single dose (1 film-coated tablet) 3.1 3.6 4.2 5.0 1.67 - 5
No clinical data are available on doses of AugmentinTM 4:1
formulations higher than 40 mg/10 mg/kg per day in children under 2
years. Elderly No dose adjustment is considered necessary. Renal
impairment Dose adjustments are based on the maximum recommended
level of amoxicillin. No adjustment in dose is required in patients
with creatinine clearance (CrCl) greater than 30 ml/min. Adults and
children ≥ 40 kg
CrCl: 10-30 ml/min 500 mg/125 mg twice daily CrCl < 10 ml
/min 500 mg/125 mg once daily Haemodialysis 500 mg/125 mg every 24
hours, plus 500 mg/125 mg during dialysis, to be repeated at the
end of dialysis (as serum concentrations
of both amoxicillin and clavulanic acid are decreased) Children
< 40 kg
CrCl: 10-30 ml/min 15 mg/3.75 mg/kg twice daily (maximum 500
mg/125 mg twice daily). CrCl < 10 ml/min 15 mg/3.75 mg/kg as a
single daily dose (maximum 500 mg/125 mg).
Haemodialysis 15 mg/3.75 mg/kg per day once daily.
-
Page 2 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 156 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6687 Date of Preparation: September 2020
Prior to haemodialysis 15 mg/3.75 mg/kg. In order to restore
circulating drug levels, 15 mg/3.75 mg per kg should be
administered after haemodialysis.
Hepatic impairment Dose with caution and monitor hepatic
function at regular intervals (see sections Contraindications and
Warnings and Precautions). Method of administration AugmentinTM is
for oral use. Administer at the start of a meal to minimise
potential gastrointestinal intolerance and optimise absorption of
amoxicillin/clavulanic acid. Therapy can be started parenterally
according to the prescribing information of the IV-formulation and
continued with an oral preparation. For AugmentinTM 156 mg/5 ml
suspension: Shake to loosen powder, add water as directed, invert
and shake. Shake the bottle before each dose (See Instructions for
Use/Handling). Contraindications Amoxicillin-clavulanate is
contra-indicated - in patients with a history of hypersensitivity
to beta-lactams, e.g. penicillins and cephalosporins - in patients
with a previous history of amoxicillin-clavulanate-associated
jaundice/hepatic dysfunction. Warnings and Precautions Before
initiating therapy with amoxicillin-clavulanate, careful enquiry
should be made concerning previous hypersensitivity reactions to
penicillins, cephalosporins, or other allergens. Serious and
occasionally fatal hypersensitivity (anaphylactoid) reactions have
been reported in patients on penicillin therapy. These reactions
are more likely to occur in individuals with a history of
penicillin hypersensitivity. If an allergic reaction occurs,
amoxicillin-clavulanate therapy should be discontinued and
appropriate alternative therapy instituted. Serious anaphylactoid
reactions require immediate emergency treatment with adrenaline.
Oxygen, i.v. steroids and airway management, including intubation,
may also be required. Amoxicillin-clavulanate should be avoided if
infectious mononucleosis is suspected since the occurrence of a
morbilliform rash has been associated with this condition following
the use of amoxicillin. Prolonged use may also occasionally result
in overgrowth of non-susceptible organisms. Pseudomembranous
colitis has been reported with the use of antibiotics and may range
in severity from mild to life-threatening. Therefore, it is
important to consider its diagnosis in patients who develop
diarrhoea during or after antibiotic use. If prolonged or
significant diarrhoea occurs or the patient experiences abdominal
cramps, treatment should be discontinued immediately and the
patient investigated further. In general, amoxicillin-clavulanate
is well tolerated and possesses the characteristic low toxicity of
the penicillin group of antibiotics. Periodic assessment of organ
system functions, including renal, hepatic and haematopoietic
function is advisable during prolonged therapy. Abnormal
prolongation of prothrombin time (increased INR) has been reported
rarely in patients receiving amoxicillin-clavulanate and oral
anticoagulants. Appropriate monitoring should be undertaken when
anticoagulants are prescribed concurrently. Adjustments in the dose
of oral anticoagulants may be necessary to maintain the desired
level of anticoagulation. Amoxicillin-clavulanate should be used
with caution in patients with evidence of hepatic dysfunction. In
patients with renal impairment, the dosage should be adjusted
according to the degree of impairment. In patients with reduced
urine output, crystalluria has been observed very rarely,
predominantly with parenteral therapy. During the administration of
high doses of amoxicillin, it is advisable to maintain adequate
fluid intake and urinary output in order to reduce the possibility
of amoxicillin crystalluria. Amoxicillin-clavulanate
Suspensions/Sachets/Chewable Tablets (where applicable), contain
aspartame, which is a source of phenylalanine and so should be used
with caution in patients with phenylketonuria. Interactions
Concomitant use of probenecid is not recommended. Probenecid
decreases the renal tubular secretion of amoxicillin. Concomitant
use with amoxicillin-clavulanate may result in increased and
prolonged blood levels of amoxicillin, but not of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin
can increase the likelihood of allergic skin reactions. There are
no data on the concomitant use of amoxicillin-clavulanate and
allopurinol. In common with other antibiotics,
amoxicillin-clavulanate may affect the gut flora, leading to lower
oestrogen reabsorption and reduced efficacy of combined oral
contraceptives. In the literature, there are rare cases of
increased international normalised ratio in patients maintained on
acenocoumarol or warfarin and prescribed a course of amoxicillin.
If coadministration is necessary, the prothrombin time or
international normalised ratio should be carefully monitored with
the addition or withdrawal of amoxicillin. In patients receiving
mycophenolate mofetil, reduction in the pre-dose concentration of
the active metabolite mycophenolic acid of approximately 50% has
been reported following commencement of oral amoxicillin plus
clavulanic acid. The change in the pre-dose level may not
accurately represent changes in overall MPA exposure. Pregnancy and
Lactation Fertility No Text. Pregnancy Reproduction studies in
animals (mice and rats at doses up to 10 times the human dose) with
orally and parenterally administered amoxicillin-clavulanate have
shown no teratogenic effects. In a single study in women with
pre-term, premature rupture of the foetal membrane (pPROM), it was
reported that prophylactic treatment with amoxicillin-clavulanate
may be associated with an increased risk of necrotising
enterocolitis in neonates. As with all medicines, use should be
avoided in pregnancy, unless considered essential by the physician.
Lactation Amoxicillin-clavulanate may be administered during the
period of lactation. With the exception of the risk of
sensitization, associated with the excretion of trace quantities in
breast milk, there are no known detrimental effects for the
breast-fed infant.
-
Page 3 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 156 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6687 Date of Preparation: September 2020
Ability to perform tasks that require judgement, motor or
cognitive skills Adverse effects on the ability to drive or operate
machinery have not been observed. Adverse Reactions Data from large
clinical trials were used to determine the frequency of very common
to rare undesirable effects. The frequencies assigned to all other
undesirable effects (i.e., those occurring at 1/10 common >1/100
and 1/1000 and 1/10,000 and
-
Page 4 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 156 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6687 Date of Preparation: September 2020
Amoxicillin-clavulanate can be removed from the circulation by
haemodialysis. Children (additional statement): A prospective study
of 51 paediatric patients at a poison control centre suggested that
overdosages of less than 250 mg/kg of amoxicillin are not
associated with significant clinical symptoms and do not require
gastric emptying. Drug abuse and dependence Drug dependency,
addiction and recreational abuse have not been reported as a
problem with this compound. PHARMACEUTICAL DATA List of Excipients
AugmentinTM 156 mg/5 ml suspension: The powder contains xanthan
gum, hydroxypropyl methylcellulose, aspartame, silicon dioxide,
colloidal silica, succinic acid, raspberry, orange and golden syrup
dry flavours. Incompatibilities None. Shelf life AugmentinTM 156
mg/5 ml suspension: Dry powder: As indicated on the outer
packaging. Reconstituted suspensions: should be kept in a
refrigerator (but not frozen) and used within 7 days. Special
precautions for storage Store in a dry place at 30°C or below.
AugmentinTM 156 mg/5 ml suspension: Before reconstitution, keep
tightly closed and store in a dry place at 30°C or below. Once
reconstituted, store in a refrigerator and use within 7 days. Do
not freeze. AugmentinTM 625 mg tablets: Store in the original
package in order to protect from moisture. Use within 14 days of
opening. Nature and Contents of Container AugmentinTM 156 mg/5 ml
suspension: Clear glass bottles containing powder for
reconstitution to 100 ml. The bottle is supplied in a carton. Not
all pack sizes may be marketed. Instructions for Use/Handling
AugmentinTM 625 mg tablets: None AugmentinTM 156 mg/5 ml
suspension: When first reconstituted allow to stand for 5 minutes
to ensure full dispersion. Check cap seal is intact before using.
Shake bottle to loosen powder. Add the volume of water (as
indicated below) invert and shake well. Alternatively fill the
bottle with water to just below the mark on the bottle label,
invert and shake well, then top up with water exactly to the mark,
invert and again shake well
Strength The volume of water to be added at reconstitution
(ml)
The final volume of reconstituted oral suspension (ml)
156 mg /5 ml 92 100 Shake the bottle well before each dose.
Manufactured by: SmithKline Beecham Limited* Worthing, United
Kingdom *Member of the GlaxoSmithKline group of companies AUGMENTIN
is a trademark of the GlaxoSmithKline group of companies. © 2014
GlaxoSmithKline group of companies. All rights reserved. GDS
Version Number: 21 Version Date: 18 January 2013 Detailed
information on this medicinal product can be requested Via:
[email protected] To report Adverse Event/s associated with the
use of GSK product/s, please contact us via [email protected] All
Quality complaints should be reported to the LOC Quality department
mailbox [email protected]. Department of
Pharmacovigilance & Drug Information Directorate General of
Pharmaceutical Affairs & Drug Control Ministry of Health,
Sultanate of Oman Phone Nos. 0096822357687 / 0096822357686 Fax:
0096822358489 Email: [email protected] Website: www.moh.gov.om
Prescribing information for Oman Prepared September 2020 from the
summary of product characteristics version with Date of first
authorisation: 18 January 2013
mailto:[email protected]
-
Page 5 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 156 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6687 Date of Preparation: September 2020
Abbreviated Prescribing Information for Oman
Augmentin™ 156 mg/5 ml suspension Amoxicillin trihydrate -
Potassium clavulanate
QUALITATIVE AND QUANTITATIVE COMPOSITION AugmentinTM 156 mg/5 ml
suspension: When reconstituted each 5 ml contains 125 mg
amoxicillin (as amoxicillin trihydrate) PHARMACEUTICAL FORMS
AugmentinTM 156 mg/5 ml suspension: Powder for oral suspension. Dry
powder for reconstitution in water, at time of dispensing, to form
fruit flavoured suspension. Therapeutic Indications AugmentinTM is
indicated for the treatment of the following infections in adults
and children: Acute bacterial sinusitis, Acute otitis media, acute
exacerbations of chronic bronchitis, Community-acquired pneumonia,
Cystitis, Pyelonephritis, Skin and soft tissue infections in
particular cellulitis, animal bites, severe dental abscess with
spreading cellulitis, Bone and joint infections, in particular
osteomyelitis. Method of Administration For adults and children ≥
40 kg, these formulations of AugmentinTM provide a total daily dose
of 1500 mg amoxicillin/375 mg clavulanic acid. For children < 40
kg, these formulations of AugmentinTM provide a maximum daily dose
of 2400 mg amoxicillin/600 mg clavulanic acid. The duration of
therapy should be determined by the response of the patient.
Treatment should not be extended beyond 14 days without
review.Method of administration AugmentinTM is for oral use.
Administer at the start of a meal to minimise potential
gastrointestinal intolerance and optimise absorption of
amoxicillin/clavulanic acid. Therapy can be started parenterally
according to the prescribing information of the IV-formulation and
continued with an oral preparation. For AugmentinTM 156 mg/5 ml
suspension: Shake to loosen powder, add water as directed, invert
and shake. Shake the bottle before each dose Contraindications
Amoxicillin-clavulanate is contraindicated in patients with a
history of hypersensitivity to beta-lactams, e.g. penicillins and
cephalosporins Or with a previous history of
amoxicillin-clavulanate-associated jaundice/hepatic
dysfunction.Warnings and Precautions Before initiating therapy with
amoxicillin-clavulanate, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins, cephalosporins,
or other allergens. Serious and occasionally fatal hypersensitivity
(anaphylactoid) reactions have been reported in patients on
penicillin therapy. These reactions are more likely to occur in
individuals with a history of penicillin hypersensitivity. If an
allergic reaction occurs, amoxicillin-clavulanate therapy should be
discontinued and appropriate alternative therapy instituted.
Serious anaphylactoid reactions require immediate emergency
treatment with adrenaline. Oxygen, i.v. steroids and airway
management, including intubation, may also be required.
Amoxicillin-clavulanate should be avoided if infectious
mononucleosis is suspected since the occurrence of a morbilliform
rash has been associated with this condition following the use of
amoxicillin. Prolonged use may also occasionally result in
overgrowth of non-susceptible organisms. Pseudomembranous colitis
has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important
to consider its diagnosis in patients who develop diarrhoea during
or after antibiotic use. If prolonged or significant diarrhoea
occurs or the patient experiences abdominal cramps, treatment
should be discontinued immediately and the patient investigated
further.In general, amoxicillin-clavulanate is well tolerated and
possesses the characteristic low toxicity of the penicillin group
of antibiotics. Periodic assessment of organ system functions,
including renal, hepatic and haematopoietic function is advisable
during prolonged therapy. Abnormal prolongation of prothrombin time
(increased INR) has been reported rarely in patients receiving
amoxicillin-clavulanate and oral anticoagulants. Appropriate
monitoring should be undertaken when anticoagulants are prescribed
concurrently. Adjustments in the dose of oral anticoagulants may be
necessary to maintain the desired level of anticoagulation.
Amoxicillin-clavulanate should be used with caution in patients
with evidence of hepatic dysfunction. In patients with renal
impairment, the dosage should be adjusted according to the degree
of impairment. In patients with reduced urine output, crystalluria
has been observed very rarely, predominantly with parenteral
therapy. During the administration of high doses of amoxicillin, it
is advisable to maintain adequate fluid intake and urinary output
in order to reduce the possibility of amoxicillin crystalluria.
Amoxicillin-clavulanate Suspensions/Sachets/Chewable Tablets (where
applicable), contain aspartame, which is a source of phenylalanine
and so should be used with caution in patients with
phenylketonuria.Interactions Concomitant use of probenecid is not
recommended. Probenecid decreases the renal tubular secretion of
amoxicillin. Concomitant use with amoxicillin-clavulanate may
result in increased and prolonged blood levels of amoxicillin, but
not of clavulanic acid. Concomitant use of allopurinol during
treatment with amoxicillin can increase the likelihood of allergic
skin reactions. There are no data on the concomitant use of
amoxicillin-clavulanate and allopurinol. In common with other
antibiotics, amoxicillin-clavulanate may affect the gut flora,
leading to lower oestrogen reabsorption and reduced efficacy of
combined oral contraceptives. In the literature, there are rare
cases of increased international normalised ratio in patients
maintained on acenocoumarol or warfarin and prescribed a course of
amoxicillin. If coadministration is necessary, the prothrombin time
or international normalised ratio should be carefully monitored
with the addition or withdrawal of amoxicillin. In patients
receiving mycophenolate mofetil, reduction in the pre-dose
concentration of the active metabolite mycophenolic acid of
approximately 50% has been reported following commencement of oral
amoxicillin plus clavulanic acid. The change in the pre-dose level
may not accurately represent changes in overall MPA exposure.
Pregnancy As with all medicines, use should be avoided in
pregnancy, unless considered essential by the physician.Lactation
Amoxicillin-clavulanate may be administered during the period of
lactation With the exception of the risk of sensitization Adverse
Reactions common Mucocutaneous candidiasis, Diarrhoea, Nausea,
vomiting. If any hypersensitivity dermatitis reaction occurs,
treatment should be discontinued. Overdosage Treatment GI symptoms
may be treated symptomatically, with attention to the
water/electrolyte balance. Amoxicillin-clavulanate can be removed
from the circulation by haemodialysis. PHARMACEUTICAL DATA List of
Excipients AugmentinTM 156 mg/5 ml: The powder contains xanthan
gum, hydroxypropyl methylcellulose, aspartame, silicon dioxide,
colloidal silica, succinic acid, raspberry, orange and golden syrup
dry flavours. Shelf life AugmentinTM 156 mg/5 ml suspension: Dry
powder: As indicated on the outer packaging. Reconstituted
suspensions: should be kept in a refrigerator (but not frozen) and
used within 7 days. Special precautions for storage Store in a dry
place at 30°C or below. AugmentinTM 156 mg/5 ml suspension: Before
reconstitution, keep tightly closed and store in a dry place at
30°C or below. Once reconstituted, store in a refrigerator and use
within 7 days. Do not freeze. Nature and Contents of Container
AugmentinTM 156 mg/5 ml suspension: Clear glass bottles containing
powder for reconstitution to 100 ml. The bottle is supplied in a
carton. Manufactured by: SmithKline Beecham Limited* Worthing,
United Kingdom *Member of the GlaxoSmithKline group of companies
AUGMENTINTM is a trademark of the GlaxoSmithKline group of
companies. © 2014 GlaxoSmithKline group of companies. All rights
reserved. GDS Version Number: 21 Version Date: 18 January 2013
Detailed information on this medicinal product can be requested
Via: [email protected] To report Adverse Event/s associated with
the use of GSK product/s, please contact us via [email protected]
All Quality complaints should be reported to the LOC Quality
department mailbox [email protected]. Department
of Pharmacovigilance & Drug Information Directorate General of
Pharmaceutical Affairs & Drug Control Ministry of Health,
Sultanate of Oman Phone Nos. 0096822357687 / 0096822357686 Fax:
0096822358489 Email: [email protected] Website: www.moh.gov.om
Prescribing information for Oman Prepared September 2020 from the
summary of product characteristics version with Date of first
authorisation: 18 January 2013.
mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.moh.gov.om/
-
Page 1 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 312 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6688 Date of Preparation: September 2020
Prescribing Information for Oman Augmentin™ 312 mg/5 ml
suspension
Amoxicillin trihydrate - Potassium clavulanate QUALITATIVE AND
QUANTITATIVE COMPOSITION AugmentinTM 312 mg/5 ml suspension: When
reconstituted each 5 ml contains 250 mg amoxicillin (as amoxicillin
trihydrate) and 62.5 mg clavulanic acid (as potassium clavulanate).
For a full list of excipients, see section ‘List of Excipients’.
PHARMACEUTICAL FORMS AugmentinTM 312 mg/5 ml suspension: Powder for
oral suspension. Dry powder for reconstitution in water, at time of
dispensing, to form fruit flavoured suspension. CLINICAL
PARTICULARS Therapeutic Indications AugmentinTM is indicated for
the treatment of the following infections in adults and children: •
Acute bacterial sinusitis (adequately diagnosed) • Acute otitis
media • Acute exacerbations of chronic bronchitis (adequately
diagnosed) • Community-acquired pneumonia • Cystitis •
Pyelonephritis • Skin and soft tissue infections in particular
cellulitis, animal bites, severe dental abscess with spreading
cellulitis • Bone and joint infections, in particular,
osteomyelitis Consideration should be given to official guidance on
the appropriate use of antibacterial agents. Posology and Method of
Administration Doses are expressed throughout in terms of
amoxicillin/clavulanic acid content except when doses are stated in
terms of an individual component. The dose of AugmentinTM that is
selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents. • The severity and the site of the infection
• The age, weight and renal function of the patient as shown below.
The use of alternative presentations of AugmentinTM (e.g. those
that provide higher doses of amoxicillin and/or different ratios of
amoxicillin to clavulanic acid) should be considered as necessary.
For adults and children ≥ 40 kg, these formulations of AugmentinTM
provide a total daily dose of 1500 mg amoxicillin/375 mg clavulanic
acid when administered as recommended below. For children < 40
kg, these formulations of AugmentinTM provide a maximum daily dose
of 2400 mg amoxicillin/600 mg clavulanic acid when administered as
recommended below. If it is considered that a higher daily dose of
amoxicillin is required, it is recommended that another preparation
of AugmentinTM is selected in order to avoid administration of
unnecessarily high daily doses of clavulanic acid. The duration of
therapy should be determined by the response of the patient. Some
infections (e.g. osteomyelitis) require longer periods of
treatment. Treatment should not be extended beyond 14 days without
review (see Warnings and Precautions for Use regarding prolonged
therapy). Adults and children ≥ 40 kg One 500 mg/125 mg dose is
taken three times a day. Children < 40 kg 20 mg/5 mg/kg/day to
60 mg/15 mg/kg/day given in three divided doses. Children may be
treated with AugmentinTM tablets, suspensions or paediatric
sachets. Children aged 6 years and below or weighing less than 25
kg should preferably be treated with Augmentin suspension or
paediatric sachets. The table below presents the received dose
(mg/kg body weight) in children weighing 25 kg to 40 kg upon
administering a single 500/125 mg tablet.
Body weight [kg] 40 35 30 25 Single dose recommended [mg/kg body
weight] (see above) Amoxicillin [mg/kg body weight] per single dose
(1 film-coated tablet)
12.5 14.3 16.7 20.0 6.67 – 20
Clavulanic acid [mg/kg body weight] per single dose (1
film-coated tablet)
3.1 3.6 4.2 5.0 1.67 - 5
No clinical data are available on doses of AugmentinTM 4:1
formulations higher than 40 mg/10 mg/kg per day in children under 2
years. Elderly No dose adjustment is considered necessary. Renal
impairment Dose adjustments are based on the maximum recommended
level of amoxicillin. No adjustment in dose is required in patients
with creatinine clearance (CrCl) greater than 30 ml/min. Adults and
children ≥ 40 kg
CrCl: 10-30 ml/min 500 mg/125 mg twice daily CrCl < 10 ml
/min 500 mg/125 mg once daily Haemodialysis 500 mg/125 mg every 24
hours, plus 500 mg/125 mg during dialysis, to be repeated at the
end of dialysis (as serum concentrations
of both amoxicillin and clavulanic acid are decreased) Children
< 40 kg
CrCl: 10-30 ml/min 15 mg/3.75 mg/kg twice daily (maximum 500
mg/125 mg twice daily). CrCl < 10 ml/min 15 mg/3.75 mg/kg as a
single daily dose (maximum 500 mg/125 mg).
-
Page 2 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 312 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6688 Date of Preparation: September 2020
Haemodialysis 15 mg/3.75 mg/kg per day once daily. Prior to
haemodialysis 15 mg/3.75 mg/kg. In order to restore circulating
drug levels, 15 mg/3.75 mg per kg should be administered after
haemodialysis.
Hepatic impairment Dose with caution and monitor hepatic
function at regular intervals (see sections Contraindications and
Warnings and Precautions). Method of administration AugmentinTM is
for oral use. Administer at the start of a meal to minimise
potential gastrointestinal intolerance and optimise absorption of
amoxicillin/clavulanic acid. Therapy can be started parenterally
according to the prescribing information of the IV-formulation and
continued with an oral preparation. For AugmentinTM 156 mg/5 ml
suspension and AugmentinTM 312 mg/5 ml suspension: Shake to loosen
powder, add water as directed, invert and shake. Shake the bottle
before each dose (See Instructions for Use/Handling).
Contraindications Amoxicillin-clavulanate is contra-indicated - in
patients with a history of hypersensitivity to beta-lactams, e.g.
penicillins and cephalosporins - in patients with a previous
history of amoxicillin-clavulanate-associated jaundice/hepatic
dysfunction. Warnings and Precautions Before initiating therapy
with amoxicillin-clavulanate, careful enquiry should be made
concerning previous hypersensitivity reactions to penicillins,
cephalosporins, or other allergens. Serious and occasionally fatal
hypersensitivity (anaphylactoid) reactions have been reported in
patients on penicillin therapy. These reactions are more likely to
occur in individuals with a history of penicillin hypersensitivity.
If an allergic reaction occurs, amoxicillin-clavulanate therapy
should be discontinued and appropriate alternative therapy
instituted. Serious anaphylactoid reactions require immediate
emergency treatment with adrenaline. Oxygen, i.v. steroids and
airway management, including intubation, may also be required.
Amoxicillin-clavulanate should be avoided if infectious
mononucleosis is suspected since the occurrence of a morbilliform
rash has been associated with this condition following the use of
amoxicillin. Prolonged use may also occasionally result in
overgrowth of non-susceptible organisms. Pseudomembranous colitis
has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important
to consider its diagnosis in patients who develop diarrhoea during
or after antibiotic use. If prolonged or significant diarrhoea
occurs or the patient experiences abdominal cramps, treatment
should be discontinued immediately and the patient investigated
further. In general, amoxicillin-clavulanate is well tolerated and
possesses the characteristic low toxicity of the penicillin group
of antibiotics. Periodic assessment of organ system functions,
including renal, hepatic and haematopoietic function is advisable
during prolonged therapy. Abnormal prolongation of prothrombin time
(increased INR) has been reported rarely in patients receiving
amoxicillin-clavulanate and oral anticoagulants. Appropriate
monitoring should be undertaken when anticoagulants are prescribed
concurrently. Adjustments in the dose of oral anticoagulants may be
necessary to maintain the desired level of anticoagulation.
Amoxicillin-clavulanate should be used with caution in patients
with evidence of hepatic dysfunction. In patients with renal
impairment, the dosage should be adjusted according to the degree
of impairment. In patients with reduced urine output, crystalluria
has been observed very rarely, predominantly with parenteral
therapy. During the administration of high doses of amoxicillin, it
is advisable to maintain adequate fluid intake and urinary output
in order to reduce the possibility of amoxicillin crystalluria.
Amoxicillin-clavulanate Suspensions/Sachets/Chewable Tablets (where
applicable), contain aspartame, which is a source of phenylalanine
and so should be used with caution in patients with
phenylketonuria. Interactions Concomitant use of probenecid is not
recommended. Probenecid decreases the renal tubular secretion of
amoxicillin. Concomitant use with amoxicillin-clavulanate may
result in increased and prolonged blood levels of amoxicillin, but
not of clavulanic acid. Concomitant use of allopurinol during
treatment with amoxicillin can increase the likelihood of allergic
skin reactions. There are no data on the concomitant use of
amoxicillin-clavulanate and allopurinol. In common with other
antibiotics, amoxicillin-clavulanate may affect the gut flora,
leading to lower oestrogen reabsorption and reduced efficacy of
combined oral contraceptives. In the literature, there are rare
cases of increased international normalised ratio in patients
maintained on acenocoumarol or warfarin and prescribed a course of
amoxicillin. If coadministration is necessary, the prothrombin time
or international normalised ratio should be carefully monitored
with the addition or withdrawal of amoxicillin. In patients
receiving mycophenolate mofetil, reduction in the pre-dose
concentration of the active metabolite mycophenolic acid of
approximately 50% has been reported following commencement of oral
amoxicillin plus clavulanic acid. The change in the pre-dose level
may not accurately represent changes in overall MPA exposure
Pregnancy and Lactation Fertility No Text. Pregnancy
Reproduction studies in animals (mice and rats at doses up to 10
times the human dose) with orally and parenterally administered
amoxicillin-clavulanate have shown no teratogenic effects. In a
single study in women with pre-term, premature rupture of the
foetal membrane (pPROM), it was reported that prophylactic
treatment with amoxicillin-clavulanate may be associated with an
increased risk of necrotising enterocolitis in neonates. As with
all medicines, use should be avoided in pregnancy, unless
considered essential by the physician.
-
Page 3 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 312 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6688 Date of Preparation: September 2020
Lactation Amoxicillin-clavulanate may be administered during the
period of lactation. With the exception of the risk of
sensitization, associated with the excretion of trace quantities in
breast milk, there are no known detrimental effects for the
breast-fed infant. Ability to perform tasks that require judgement,
motor or cognitive skills Adverse effects on the ability to drive
or operate machinery have not been observed. Adverse Reactions Data
from large clinical trials was used to determine the frequency of
very common to rare undesirable effects. The frequencies assigned
to all other undesirable effects (i.e., those occurring at 1/10
common >1/100 and 1/1000 and 1/10,000 and
-
Page 4 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 312 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6688 Date of Preparation: September 2020
Amoxicillin crystalluria, in some cases leading to renal
failure, has been observed. Treatment GI symptoms may be treated
symptomatically, with attention to the water/electrolyte balance.
Amoxicillin-clavulanate can be removed from the circulation by
haemodialysis. Children (additional statement): A prospective study
of 51 paediatric patients at a poison control centre suggested that
overdosages of less than 250 mg/kg of amoxicillin are not
associated with significant clinical symptoms and do not require
gastric emptying. Drug abuse and dependence Drug dependency,
addiction and recreational abuse have not been reported as a
problem with this compound. PHARMACEUTICAL DATA List of Excipients
AugmentinTM 156 mg/5 ml suspension and AugmentinTM 312 mg/5 ml
suspension: The powder contains xanthan gum, hydroxypropyl
methylcellulose, aspartame, silicon dioxide, colloidal silica,
succinic acid, raspberry, orange and golden syrup dry flavours.
AugmentinTM 625 mg tablets: Each tablet contains magnesium
stearate, sodium starch glycollate, colloidal silica,
microcrystalline cellulose, titanium dioxide (E171), hydroxypropyl
methylcellulose, polyethylene glycol and silicone oil.
Incompatibilities None. Shelf life AugmentinTM 312 mg/ 5ml
suspension: Dry powder: As indicated on outer packaging.
Reconstituted suspensions: should be kept in a refrigerator (but
not frozen) and used within 7 days. Special precautions for storage
Store in a dry place at 30°C or below. AugmentinTM 312 mg/ 5ml
suspension: Before reconstitution, keep tightly closed and store in
a dry place at 30°C or below. Once reconstituted, store in a
refrigerator and use within 7 days. Do not freeze. Nature and
Contents of Container AugmentinTM 312 mg/5 ml suspension: Clear
glass bottles containing powder for reconstitution to 60 or 100 ml
or 20 ml (with a plastic dosing syringe). The 100 ml bottle is
supplied in a carton. Not all pack sizes may be marketed.
Instructions for Use/Handling AugmentinTM 312 mg/ 5ml suspension:
When first reconstituted allow to stand for 5 minutes to ensure
full dispersion. Check cap seal is intact before using. Shake
bottle to loosen powder. Add the volume of water (as indicated
below) invert and shake well. Alternatively fill the bottle with
water to just below the mark on the bottle label, invert and shake
well, then top up with water exactly to the mark, invert and again
shake well
Strength The volume of water to be added at reconstitution
(ml)
The final volume of reconstituted oral suspension (ml)
312 mg /5 ml 90 100 Shake the bottle well before each dose.
Manufactured by: SmithKline Beecham Limited* Worthing, United
Kingdom *Member of the GlaxoSmithKline group of companies AUGMENTIN
is a trademark of the GlaxoSmithKline group of companies. © 2014
GlaxoSmithKline group of companies. All rights reserved. GDS
Version Number: 21 Version Date: 18 January 2013 Detailed
information on this medicinal product can be requested Via:
[email protected] To report Adverse Event/s associated with the
use of GSK product/s, please contact us via [email protected] All
Quality complaints should be reported to the LOC Quality department
mailbox [email protected]. Department of
Pharmacovigilance & Drug Information Directorate General of
Pharmaceutical Affairs & Drug Control Ministry of Health,
Sultanate of Oman Phone Nos. 0096822357687 / 0096822357686 Fax:
0096822358489 Email: [email protected] Website: www.moh.gov.om
Prescribing information for Oman Prepared September 2020 from the
summary of product characteristics version with Date of first
authorisation: 18 January 2013
mailto:[email protected]
-
Page 5 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 312 mg/5 ml suspension
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6688 Date of Preparation: September 2020
Abbreviated Prescribing Information for Oman Augmentin™ 312 mg/5
ml suspension
Amoxicillin trihydrate - Potassium clavulanate
QUALITATIVE AND QUANTITATIVE COMPOSITION: AugmentinTM 312 mg/5
ml suspension: When reconstituted each 5 ml contains 250 mg
amoxicillin (as amoxicillin trihydrate) and 62.5 mg clavulanic acid
(as potassium clavulanate). PHARMACEUTICAL FORMS: AugmentinTM 312
mg/5 ml suspension: Powder for oral suspension. Dry powder for
reconstitution in water, at time of dispensing, to form fruit
flavoured suspension.Therapeutic Indications: AugmentinTM is
indicated for the treatment of the following infections in adults
and children: Acute bacterial sinusitis, Acute otitis media, acute
exacerbations of chronic bronchitis, Community-acquired pneumonia,
Cystitis, Pyelonephritis, Skin and soft tissue infections in
particular cellulitis, animal bites, severe dental abscess with
spreading cellulitis, Bone and joint infections, in particular
osteomyelitis. Method of Administration: For adults and children ≥
40 kg, these formulations of AugmentinTM provide a total daily dose
of 1500 mg amoxicillin/375 mg clavulanic acid. For children < 40
kg, these formulations of AugmentinTM provide a maximum daily dose
of 2400 mg amoxicillin/600 mg clavulanic acid. The duration of
therapy should be determined by the response of the patient.
Treatment should not be extended beyond 14 days without
review.Method of administration: AugmentinTM is for oral use.
Administer at the start of a meal to minimise potential
gastrointestinal intolerance and optimise absorption of
amoxicillin/clavulanic acid. Therapy can be started parenterally
according to the prescribing information of the IV-formulation and
continued with an oral preparation.For AugmentinTM 156 mg/5 ml
suspension and AugmentinTM 312 mg/5 ml suspension: Shake to loosen
powder, add water as directed, invert and shake. Shake the bottle
before each dose Contraindications: Amoxicillin-clavulanate is
contraindicated in patients with a history of hypersensitivity to
beta-lactams, e.g. penicillins and cephalosporins or with a
previous history of amoxicillin-clavulanate-associated
jaundice/hepatic dysfunction. Warnings and Precautions: Before
initiating therapy with amoxicillin-clavulanate, careful enquiry
should be made concerning previous hypersensitivity reactions to
penicillins, cephalosporins, or other allergens. Serious and
occasionally fatal hypersensitivity (anaphylactoid) reactions have
been reported in patients on penicillin therapy. These reactions
are more likely to occur in individuals with a history of
penicillin hypersensitivity. If an allergic reaction occurs,
amoxicillin-clavulanate therapy should be discontinued and
appropriate alternative therapy instituted. Serious anaphylactoid
reactions require immediate emergency treatment with adrenaline.
Oxygen, i.v. steroids and airway management, including intubation,
may also be required. Amoxicillin-clavulanate should be avoided if
infectious mononucleosis is suspected since the occurrence of a
morbilliform rash has been associated with this condition following
the use of amoxicillin. Prolonged use may also occasionally result
in overgrowth of non-susceptible organisms. Pseudomembranous
colitis has been reported with the use of antibiotics and may range
in severity from mild to life-threatening. Therefore, it is
important to consider its diagnosis in patients who develop
diarrhoea during or after antibiotic use. If prolonged or
significant diarrhoea occurs or the patient experiences abdominal
cramps, treatment should be discontinued immediately and the
patient investigated further. In general, amoxicillin-clavulanate
is well tolerated and possesses the characteristic low toxicity of
the penicillin group of antibiotics. Periodic assessment of organ
system functions, including renal, hepatic and haematopoietic
function is advisable during prolonged therapy. Abnormal
prolongation of prothrombin time (increased INR) has been reported
rarely in patients receiving amoxicillin-clavulanate and oral
anticoagulants. Appropriate monitoring should be undertaken when
anticoagulants are prescribed concurrently. Adjustments in the dose
of oral anticoagulants may be necessary to maintain the desired
level of anticoagulation. Amoxicillin-clavulanate should be used
with caution in patients with evidence of hepatic dysfunction. In
patients with renal impairment, the dosage should be adjusted
according to the degree of impairment. In patients with reduced
urine output, crystalluria has been observed very rarely,
predominantly with parenteral therapy. During the administration of
high doses of amoxicillin, it is advisable to maintain adequate
fluid intake and urinary output in order to reduce the possibility
of amoxicillin crystalluria. Amoxicillin-clavulanate
Suspensions/Sachets/Chewable Tablets (where applicable), contain
aspartame, which is a source of phenylalanine and so should be used
with caution in patients with phenylketonuria. Interactions:
Concomitant use of probenecid is not recommended. Probenecid
decreases the renal tubular secretion of amoxicillin. Concomitant
use with amoxicillin-clavulanate may result in increased and
prolonged blood levels of amoxicillin, but not of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin
can increase the likelihood of allergic skin reactions. There are
no data on the concomitant use of amoxicillin-clavulanate and
allopurinol. In common with other antibiotics,
amoxicillin-clavulanate may affect the gut flora, leading to lower
oestrogen reabsorption and reduced efficacy of combined oral
contraceptives. In the literature, there are rare cases of
increased international normalised ratio in patients maintained on
acenocoumarol or warfarin and prescribed a course of amoxicillin.
If coadministration is necessary, the prothrombin time or
international normalised ratio should be carefully monitored with
the addition or withdrawal of amoxicillin. In patients receiving
mycophenolate mofetil, reduction in the pre-dose concentration of
the active metabolite mycophenolic acid of approximately 50% has
been reported following commencement of oral amoxicillin plus
clavulanic acid. The change in the pre-dose level may not
accurately represent changes in overall MPA exposure. Pregnancy: As
with all medicines, use should be avoided in pregnancy, unless
considered essential by the physician. Lactation:
Amoxicillin-clavulanate may be administered during the period of
lactation With the exception of the risk of sensitization. Adverse
Reactions: common Mucocutaneous candidiasis, Diarrhoea, Nausea,
vomiting. If any hypersensitivity dermatitis reaction occurs,
treatment should be discontinued. Overdosage Treatment: GI symptoms
may be treated symptomatically, with attention to the
water/electrolyte balance. Amoxicillin-clavulanate can be removed
from the circulation by haemodialysis. PHARMACEUTICAL DATA: List of
Excipients: AugmentinTM 312 mg/5 ml suspension: The powder contains
xanthan gum, hydroxypropyl methylcellulose, aspartame, silicon
dioxide, colloidal silica, succinic acid, raspberry, orange and
golden syrup dry flavours. Shelf life: AugmentinTM 312 mg/ 5ml
suspension: Dry powder: As indicated on the outer packaging.
Reconstituted suspensions: should be kept in a refrigerator (but
not frozen) and used within 7 days. Special precautions for
storage: Store in a dry place at 30°C or below. AugmentinTM 312 mg/
5ml suspension: Before reconstitution, keep tightly closed and
store in a dry place at 30°C or below. Once reconstituted, store in
a refrigerator and use within 7 days. Do not freeze. Nature and
Contents of Container: AugmentinTM 312 mg/5 ml suspension: Clear
glass bottles containing powder for reconstitution to 60 or 100 ml
or 20 ml (with a plastic dosing syringe). The 100 ml bottle is
supplied in a carton. Manufactured by: SmithKline Beecham Limited*
Worthing, United Kingdom *Member of the GlaxoSmithKline group of
companies AUGMENTIN is a trademark of the GlaxoSmithKline group of
companies. © 2014 GlaxoSmithKline group of companies. All rights
reserved. GDS Version Number: 21 Version Date: 18 January 2013
Detailed information on this medicinal product can be requested
Via: [email protected] To report Adverse Event/s associated with
the use of GSK product/s, please contact us via [email protected]
All Quality complaints should be reported to the LOC Quality
department mailbox [email protected]. Department
of Pharmacovigilance & Drug Information Directorate General of
Pharmaceutical Affairs & Drug Control Ministry of Health,
Sultanate of Oman Phone Nos. 0096822357687 / 0096822357686 Fax:
0096822358489 Email: [email protected] Website: www.moh.gov.om
Prescribing information for Oman Prepared September 2020 from the
summary of product characteristics version with Date of first
authorisation: 18 January 2013.
mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.moh.gov.om/
-
Page 1 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 457 mg/5 ml Mixed fruit flavour
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6689 Date of Preparation: September 2020
Prescribing Information for Oman Augmentin™ Suspension 457 mg/5
ml - Mixed fruit flavour
Amoxicillin trihydrate - Potassium clavulanate QUALITATIVE AND
QUANTITATIVE COMPOSITION AugmentinTM suspension 457 mg/5 ml
contains 400 mg amoxicillin (as amoxicillin trihydrate) and 57 mg
clavulanic acid (as potassium clavulanate) per 5 ml. For a full
list of excipients, see section ‘List of Excipients’.
PHARMACEUTICAL FORM Dry powder for reconstitution in water, at time
of dispensing, to form an oral sugar-free suspension. CLINICAL
PARTICULARS Therapeutic Indications AugmentinTM is indicated for
the treatment of the following infections in adults and children: •
Acute bacterial sinusitis (adequately diagnosed) • Acute otitis
media • Acute exacerbations of chronic bronchitis (adequately
diagnosed) • Community-acquired pneumonia • Cystitis •
Pyelonephritis • Skin and soft tissue infections in particular
cellulitis, animal bites, severe dental abscess with spreading
cellulitis. • Bone and joint infections, in particular
osteomyelitis. Consideration should be given to official guidance
on the appropriate use of antibacterial agents. Posology and Method
of Administration Doses are expressed throughout in terms of
amoxicillin/clavulanic acid content except when doses are stated in
terms of an individual component. The dose of AugmentinTM that is
selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents • The severity and the site of the infection •
The age, weight and renal function of the patient as shown below
The use of alternative presentations of AugmentinTM (e.g. those
that provide higher doses of amoxicillin and/or different ratios of
amoxicillin to clavulanic acid) should be considered as necessary.
Adults and children ≥ 40 kg For AugmentinTM suspension 457 mg/5 ml:
Elderly No dose adjustment is considered necessary. Renal
impairment No dose adjustment is required in patients with
creatinine clearance (CrCl) greater than 30 ml/min. In patients
with creatinine clearance less than 30 ml/min, the use of
AugmentinTM presentations with amoxicillin to clavulanic acid ratio
of 7:1 is not recommended, as no recommendations for dose,
adjustments are available. Hepatic impairment Dose with caution and
monitor hepatic function at regular intervals. Method of
administration AugmentinTM is for oral use. Administer at the start
of a meal to minimise potential gastrointestinal intolerance and
optimise absorption of amoxicillin/clavulanic acid. Therapy can be
started parenterally according to the prescribing information of
the IV-formulation and continued with an oral preparation. Shake to
loosen powder, add water as directed, invert and shake. Shake the
bottle before each dose (See Instructions for Use/Handling).
Contraindications Amoxicillin-clavulanate is contra-indicated: - in
patients with a history of hypersensitivity to beta-lactams, e.g.
penicillins and cephalosporins - in patients with a previous
history of amoxicillin-clavulanate-associated jaundice/hepatic
dysfunction. Warnings and Precautions Before initiating therapy
with amoxicillin-clavulanate, careful enquiry should be made
concerning previous hypersensitivity reactions to penicillins,
cephalosporins, or other allergens. Serious and occasionally fatal
hypersensitivity (anaphylactoid) reactions have been reported in
patients on penicillin therapy. These reactions are more likely to
occur in individuals with a history of penicillin hypersensitivity.
If an allergic reaction occurs, amoxicillin-clavulanate therapy
should be discontinued and appropriate alternative therapy
instituted. Serious anaphylactoid reactions require immediate
emergency treatment with adrenaline. Oxygen, i.v. steroids and
airway management, including intubation, may also be required.
Amoxicillin-clavulanate should be avoided if infectious
mononucleosis is suspected since the occurrence of a morbilliform
rash has been associated with this condition following the use of
amoxicillin. Prolonged use may also occasionally result in
overgrowth of non-susceptible organisms. Pseudomembranous colitis
has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important
to consider its diagnosis in patients who develop diarrhoea during
or after antibiotic use. If prolonged or significant diarrhoea
occurs or the patient experiences abdominal cramps, treatment
should be discontinued immediately and the patient investigated
further. In general, amoxicillin-clavulanate is well tolerated and
possesses the characteristic low toxicity of the penicillin group
of antibiotics. Periodic assessment of organ system functions,
including renal, hepatic and haematopoietic function is advisable
during prolonged therapy. Abnormal prolongation of prothrombin time
(increased INR) has been reported rarely in patients receiving
amoxicillin-clavulanate and oral anticoagulants.
-
Page 2 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 457 mg/5 ml Mixed fruit flavour
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6689 Date of Preparation: September 2020
Appropriate monitoring should be undertaken when anticoagulants
are prescribed concurrently. Adjustments in the dose of oral
anticoagulants may be necessary to maintain the desired level of
anticoagulation. Amoxicillin-clavulanate should be used with
caution in patients with evidence of hepatic dysfunction. In
patients with renal impairment, the dosage should be adjusted
according to the degree of impairment. In patients with reduced
urine output, crystalluria has been observed very rarely,
predominantly with parenteral therapy. During the administration of
high doses of amoxicillin, it is advisable to maintain adequate
fluid intake and urinary output in order to reduce the possibility
of amoxicillin crystalluria. Amoxicillin-clavulanate
Suspensions/Sachets/Chewable Tablets (where applicable), contain
aspartame, which is a source of phenylalanine and so should be used
with caution in patients with phenylketonuria. Interactions
Concomitant use of probenecid is not recommended. Probenecid
decreases the renal tubular secretion of amoxicillin. Concomitant
use with amoxicillin-clavulanate may result in increased and
prolonged blood levels of amoxicillin, but not of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin
can increase the likelihood of allergic skin reactions. There are
no data on the concomitant use of amoxicillin-clavulanate and
allopurinol. In common with other antibiotics,
amoxicillin-clavulanate may affect the gut flora, leading to lower
oestrogen reabsorption and reduced efficacy of combined oral
contraceptives. In the literature, there are rare cases of
increased international normalised ratio in patients maintained on
acenocoumarol or warfarin and prescribed a course of amoxicillin.
If coadministration is necessary, the prothrombin time or
international normalised ratio should be carefully monitored with
the addition or withdrawal of amoxicillin. In patients receiving
mycophenolate mofetil, reduction in the pre-dose concentration of
the active metabolite mycophenolic acid of approximately 50% has
been reported following commencement of oral amoxicillin plus
clavulanic acid. The change in the pre-dose level may not
accurately represent changes in overall MPA exposure. Pregnancy and
Lactation Pregnancy Reproduction studies in animals (mice and rats
at doses up to 10 times the human dose) with orally and
parenterally administered amoxicillin-clavulanate have shown no
teratogenic effects. In a single study in women with pre-term,
premature rupture of the foetal membrane (pPROM), it was reported
that prophylactic treatment with amoxicillin-clavulanate may be
associated with an increased risk of necrotising enterocolitis in
neonates. As with all medicines, use should be avoided in
pregnancy, unless considered essential by the physician. Lactation
Amoxicillin-clavulanate may be administered during the period of
lactation. With the exception of the risk of sensitization,
associated with the excretion of trace quantities in breast milk,
there are no known detrimental effects for the breast-fed infant.
Ability to perform tasks that require judgement, motor or cognitive
skills Adverse effects on the ability to drive or operate machinery
have not been observed. Adverse Reactions Data from large clinical
trials were used to determine the frequency of very common to rare
undesirable effects. The frequencies assigned to all other
undesirable effects (i.e., those occurring at 1/10 common >1/100
and 1/1000 and 1/10,000 and
-
Page 3 of 5 Prescribing Information and Abbreviated Prescribing
Information for Oman , AugmentinTM 457 mg/5 ml Mixed fruit flavour
Amoxicillin trihydrate + Potassium clavulanate Content Lab Code:
PI-6689 Date of Preparation: September 2020
Superficial tooth discolouration has been reported very rarely
in children. Good oral hygiene may help to prevent tooth
discolouration as it can usually be removed by brushing+. +This
statement is core safety for the syrup, suspension and chewable
tablet formulations. Hepatobiliary disorders Uncommon A moderate
rise in AST and/or ALT has been noted in patients treated with
beta-lactam class antibiotics, but the significance of these
findings is unknown. Very rare Hepatitis and cholestatic jaundice.
These events have been noted with other penicillins and
cephalosporins. Hepatic events have been reported predominantly in
males and elderly patients and may be associated with prolonged
treatment. Children (additional statement): These events have been
very rarely reported in children. All populations: Signs and
symptoms usually occur during or shortly after treatment but in
some cases may not become apparent until several weeks after
treatment has ceased. These are usually reversible. Hepatic events
may be severe and in extremely rare circumstances, deaths have been
reported. These have almost always occurred in patients with
serious underlying disease or taking concomitant medications known
to have the potential for hepatic effects. Skin and subcutaneous
tissue disorders Uncommon Skin rash, pruritus, urticaria Rare
Erythema multiforme Very rare Stevens-Johnson syndrome, toxic
epidermal necrolysis, bullous exfoliative-dermatitis, acute
generalised exanthemous pustulosis (AGEP) If any hypersensitivity
dermatitis reaction occurs, treatment should be discontinued. Renal
and urinary disorders Very rare Interstitial nephritis,
crystalluria. Overdosage Symptoms and Signs Gastrointestinal
symptoms and disturbance of the fluid and electrolyte balances may
be evident. Amoxicillin crystalluria, in some cases leading to
renal failure, has been observed. Treatment GI symptoms may be
treated symptomatically, with attention to the water/electrolyte
balance. Amoxicillin-clavulanate can be removed from the
circulation by haemodialysis. Children (additional statement): A
prospective study of 51 paediatric patients at a poison control
centre suggested that overdosages of less than 250 mg/kg of
amoxicillin are not associated with significant clinical symptoms
and do not require gastric emptying. Drug abuse and dependence Drug
dependency, addiction and recreational abuse have not been reported
as a problem with this compound. PHARMACEUTICAL DATA List of
Excipients Xanthan gum, hydroxypropylmethylcellulose, colloidal
silica, succinic acid, silicon dioxide, raspberry, orange “1”,
orange “2”, golden syrup dry flavours, aspartame. Incompatibilities
None known. Shelf Life The expiry date is indicated on the
packaging. Special Precautions for Storage The dry powder should be
stored in unopened containers in a dry place at below 30°C. Once
reconstituted, the suspension must be stored in a refrigerator
(2-8°C) and used within seven days. Do not freeze. Nature and
Contents of Container Clear, glass bottles with aluminium screw
caps, containing an off-white dry powder. The AugmentinTM
suspension 457 mg/5 ml 35 ml and 70 ml presentations may be
supplied with a cup dosing device. or Single-dose sachets
(AugmentinTM suspension 457 mg/5 ml only). When reconstituted, an
off-white suspension is formed. Instructions for Use/Handling Check
cap seal is intact before using. Shake bottle to loosen powder. Add
the volume of water (as indicated below) invert and shake well.
Alternatively, add water to 2/3 of fill line level, invert and
shake well, then top up with water exactly to the mark, invert and
again shake well.
Strength The volume of water to be added at reconstitution
(ml)
The final volume of reconstituted oral su
